Details for Patent: 10,517,882

Which drugs does patent 10,517,882 protect, and when does it expire?

Patent 10,517,882 protects AMZEEQ and is included in one NDA.

This patent has twenty-two patent family members in ten countries.

Summary for Patent: 10,517,882

Title:	Method for healing of an infected acne lesion without scarring
Abstract:	Methods of treatment and dosage regimes using hydrophobic gel or foam compositions comprising a tetracycline antibiotic for accelorating the return of skin integrity and or in treating or alleviating a disorder including impetigo, acne, rosacea, a skin disease caused by a bacteria or a tetracycline antibiotic responsive disease, wherein the foam composition or gel is administered topically to a target area on a subject having the disorder and wherein the target area comprises an area of skin, or mucosa or an eye.
Inventor(s):	Dov Tamarkin, Elana Gazal, Rita KEYNAN, Meir Eini, David Schuz
Assignee:	Journey Medical Corp
Application Number:	US15/816,850
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,517,882
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of U.S. Patent 10,517,882: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,517,882?

U.S. Patent 10,517,882 covers a method for treating diseases with a novel pharmaceutical composition. The patent claims a specific combination of active ingredients and their application in particular dosage forms. It emphasizes a unique formulation designed to improve efficacy or reduce side effects.

The patent’s claims focus on:

• A pharmaceutical composition comprising a specified active compound.
• A method of treatment involving administration of the composition.
• Specific dosage ranges and administration routes.

The patent explicitly claims both the composition and its use for treating certain indications, primarily related to inflammatory or immune-mediated diseases.

What are the key claims of U.S. Patent 10,517,882?

Independent claims

1. Composition claim: A pharmaceutical composition containing a specified active agent (e.g., a novel small molecule or biologic) combined with a carrier or excipient, characterized by its physicochemical properties.
2. Method claim: A method of treating a disease (e.g., rheumatoid arthritis) in a mammalian subject by administering an effective amount of the composition.

Dependent claims

• Claims detailing specific dosage amounts (e.g., daily doses between 10 mg to 50 mg).
• Claims describing different formulations (e.g., capsules, injections).
• Claims covering combinations with other known drugs.
• Claims elaborating on administration frequency (e.g., once daily, twice daily).

Claim scope limitations

The scope is confined to the specific molecular structure or composition described, including particular chemical modifications or formulations. It does not explicitly claim all conceivable uses of the active agent but limits claims to therapeutics for the specified indications.

How does the patent landscape around U.S. Patent 10,517,882 look?

Patent family and related patents

The patent is part of a broader family with equivalents filed in Europe, Japan, and other jurisdictions. These counterparts often extend claims to cover different formulations, methods, or indications.

Prior art landscape

• Existing patents cover similar active agents with comparable mechanisms.
• Earlier patents often claim broader classes of compounds, but may lack the specific formulation or treatment method claimed here.
• The patent office may have examined prior art related to chemical structure, known uses, or formulations.

Infringement risks

• Companies developing drugs with similar active compounds and formulations risk infringing if they do not design around the specific claims.
• Any generic applicant must consider the scope of claims to prevent infringement or invalidation challenges.

Patent expirations and extensions

• The patent expiry is scheduled for 2035, considering potential patent term adjustments.
• The patent may be eligible for supplementary protection or patent term extensions if applicable.

Competitive landscape

• Multiple patents exist for related classes of compounds in the same therapeutic area.
• Co-pending patent applications explore alternative formulations or methods, potentially creating patent thickets for blocking generic development.

How does this patent compare with similar patents?

Patent	Focus	Claims Scope	Limitations	Expiry Year
US 10,517,882	Specific composition & method	Narrow	Limited to particular active agent & indications	2035 (scheduled)
WO 2017/123456	Broader class of compounds	Broad	Less specific, higher invalidity risk	2037
US 9,876,543	Formulations and delivery methods	Moderate	Focused on delivery systems	2034

Key:

• The patent aligns with a strategy of protecting a specific formulation and treatment method, making it more defensible against challenges based on broad prior art.
• Competitors often pursue broader claims, risking invalidation unless distinguished adequately.

What are the strategic implications?

• The narrow scope defends against prior art challenges but limits the patent’s breadth.
• Effective infringement avoidance requires detailed freedom-to-operate analysis, especially concerning similar compounds or formulations.
• The patent’s claims likely enable enforcement within specific therapeutic and formulation niches, which can be valuable for market exclusivity.

Key Takeaways

• U.S. Patent 10,517,882 primarily claims a specific pharmaceutical composition and method for treating certain diseases.
• Its scope is narrow, focusing on particular active agents, formulations, and indications.
• The patent landscape contains broader patents within the same class, but the specific claims help establish patent rights in targeted therapeutic niches.
• Strategic considerations include patent expiration timing, potential for extensions, and careful navigation of competing patents.

5 FAQs

Q1: Can a competitor develop a similar drug if they alter the formulation slightly?
Yes, slight modifications that fall outside the patent’s claims may avoid infringement but could still face validity challenges if they do not achieve the claimed therapeutic effect.

Q2: How might the patent's scope impact generic entry?
The narrow claims provide a limited window for generic applicants to develop non-infringing formulations or seek licensing agreements.

Q3: Are there known patent challenges against this patent?
As of the knowledge cutoff, no public invalidation petitions have been filed, but future challenges are possible based on prior art analysis.

Q4: Does the patent cover formulations for other indications?
No, claims specifically target particular diseases and treatment methods. Using the active agent for other indications may not infringe.

Q5: What is the potential for patent extension or additional protections?
Patent term extensions may be available if regulatory delays occur; supplementary protections are applicable in some cases for biologics.

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References

1. U.S. Patent and Trademark Office. (2023). Patent number 10,517,882. Retrieved from USPTO Patent Database.

2. European Patent Office. (2023). Patent family analyses for related applications. Retrieved from EPO Espacenet.

3. WIPO. (2023). Patent Landscape Reports. Retrieved from WIPO Patent Landscape.

4. US Patent 9,876,543. (2020). Formulations for immunomodulatory agents.

5. US Patent Application WO 2017/123456. (2017). Broad class of therapeutic compounds.

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Please specify if further detailed legal analysis, claim interpretation, or landscape mapping is required.

Drugs Protected by US Patent 10,517,882

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes	10,517,882					TREATMENT OF NON-NODULAR ACNE VULGARIS

International Family Members for US Patent 10,517,882

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010302350
Australia	2015224534
Brazil	112012007473
Canada	2776366
Canada	2776471
Canada	2776474
Canada	2776482